Job Description

About the role

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz\xe2\x80\xa6 are you ready to make a difference?
Job Purpose:
Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QSC and business partners. Manage Quality aspects & projects within area of responsibility.

Your Key Responsibilities:

Supplier quality management:

• Drafting of Annual Monitoring and Certification report for incoming materials
• Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with Suppliers/Service providers
• Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of change record for the applicable SCN.
• Drafting and Evaluation of Supplier\'s incoming materials Specification
• Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers
• Management of Supplier/ Material qualification and supplier related documentations
• Preparation of regulatory statement for materials and finished products
• Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rd PAP Management in TPRM (Third Party Risk Management) tool

Role Requirements

• Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
• Min 4 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge
• Fluent in English (written and spoken)
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could achieve here at Sandoz!

Functional Area

Quality

Division

SANDOZ

Business Unit

Quality STO

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis